OUTLINE: Patients are randomized into IPHC group and control group. In the former group, the patients undergo cytoreductive surgery plus intraoperative hyperthermic peritoneal perfusion with cisplatin and mitomycin over 60 minutes. Patients in the control group just underwent routine cytoreductive surgery.

All patients in both groups receive the standard conventional chemotherapy after surgery.

Quality of life is assessed at study initiation, at 1, 3, 6 months. Patients are followed at 4 weeks, every 3 months for 1 year, and then every 6 months for up to 3 years.

Immediately after the cytoreductive surgery, cisplatin and mitomycin C dissolved in 12,000 ml of normal saline heated to 42 degrees celsius is infused into the abdominal cavity for a sustained hyperthermic intraperitoneal chemotherapy for 60 to 90 minutes.

Other Name: HIPEC

Active Comparator: B

cytoreductive surgery alone, postoperative chemotherapy.

Procedure: cytoreductive surgery

the whole abdominal-pelvic cavity is explored and maximal cytoreductive surgery is performed to remove visible tumor burden as much as possible.

Detailed Description:

DISEASE CHARACTERISTICS:

Histologically confirmed peritoneal carcinomatosis with the following histologies:

Primary peritoneal mesothelioma

Adenocarcinoma of gastrointestinal tract origin

Confined to peritoneal cavity

Tumor mass could be debulked to less than 2.5 cm in diameter per tumor deposit

Must not have failed prior intraperitoneal platinum therapy

Treatment failure is defined as radiographic evidence of disease progression on 2 consecutive CT scans within 3 months after therapy

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00454519